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- 2026-04-30 19:05:31
- Opinion
- [Reporter’s View] Accepting drugs used by very few patients
- by Eo, Yun-Ho Mar 30, 2023 05:41am
- It's the same 'cancer', but different. So how should we regard these new anticancer drugs that target only a very few among all patients that have the same type of cancer? The cancer types that we commonly refer to, such as liver cancer, stomach cancer, and lung cancer are just major categories used, and the specific condition of each patient is classified in more detail. According to the specific class of cancer, the difficulty of treatment may vary even for tumors that originate from the same organ and affect a varying number of patients. The development of precision medicine is already heralding a shift in the prescription standards from organs to genes. In other words, the era of personalized healthcare has now arrived but is still regarded as an unfamiliar concept by many. Korea is still having difficulty accepting cutting-edge targeted anticancer therapies that show an effect regardless of cancer type according to each patient’s identified gene mutation. In this sense, targeted anticancer therapies and cancer immunotherapies that have previously been listed are experiencing considerable difficulties in the process of extending their reimbursement. This is due not only to the high price of the drugs but also because the drugs need to undergo value assessments again and reestimate their amount of use. This is the key framework that sustains Korea's national health insurance system. However, one of the characteristics of the recently developed new drugs is that the number of subject patients, that is, the number of patients confirmed with the specific genetic mutations that allow the use of such new drugs is very small. In other words, there are not many people who are eligible to use the new drugs. Less than 1% of all solid cancer patients have a rare type of solid cancer, and in terms of diagnosis, around 200 are diagnosed with such rare conditions in Korea. The typical standard-of-care therapies (existing drugs) do not work well in these patients. This was why industry voices have been on the need to redefine rare diseases. In other words, the number of patients corresponding to each treatment option should be reflected rather than the number of patients that are affected by the same disease. Of course, such redefinition would require systematic and detailed discussions. However, the time has now come for Korea to consider how to reimburse the new targeted anticancer drugs whose use has increased and targets reduced. Korea's current system is not the issue. Korea just need to consider how to solve the problem regarding the increasing number of anticancer drugs difficult to reimburse through the current system.
- Opinion
- [Reporter's view] The goal of global new drug development
- by Hwang, Jin-joon Mar 28, 2023 05:54am
- When the government announced the 'Third Five-Year Comprehensive Plan to Foster and Support the Pharmaceutical Bio Industry', it was emphasized that it would create three new blockbuster drugs that record global sales of more than 1 trillion won by 2030. For this purpose, strategic R&D investment was selected as a key task. In the development of new drugs, it is planned to significantly increase public and private R&D investment. Looking at the detailed support measures, the government plans to promote R&D investment of a total of 25 trillion won jointly with the private sector for 5 years with 10 global new drug development goals. The government also expects to invest 4 trillion won in government R&D and 21 trillion won in private R&D from this year to 2027. Based on the national new drug development project that inherited the results of the pan-governmental new drug development project from 2011 to 2020, a joint public-private investment of 2.2 trillion won was invested to develop one new blockbuster drug and three new drugs by 2035. A plan for development was also established. The government's will to foster the industry is positive, but the problem with new drug development is that speed is not important. As of last year, there were zero blockbuster new drugs recognized by the government. The government expects to secure two by 2027. Under the current circumstances, only Yuhan's non-small cell lung cancer drug Leclaza and SK Biopharmaceuticals' epilepsy drug Xcopri appear to be the only drugs developed by domestic biopharmaceutical companies by 2027 that have the potential to become global blockbusters. Leclaza was transferred from Genosco/Oscotec to Yuhan Corporation in July 2015 when preclinical development was underway. In November 2018, the technology was transferred from Yuhan to Janssen, a subsidiary of J&J, a global pharmaceutical company. Yuhan received conditional approval for Leclaza as a treatment for secondary mutations in non-small cell lung cancer in Korea in 2021. In other words, it took five and a half years from preclinical trials to conditional approval. It seems that it will take more time for Leclaza to rise to prominence as a global blockbuster. Janssen, which holds the global copyright, is conducting a phase 3 trial of Leclaza alone and Rybrevant as an indication for non-small cell lung cancer. Cenobamate started with basic research in 2001, went through clinical trials and licensing, and was approved by the U.S. Food and Drug Administration (FDA) in 2019. It took 18 years from the first research to enter the large-scale US pharmaceutical market. Last year, US sales of Cenobamate more than doubled from the previous year to 169.2 billion won, but it will take more time to get on the list of global blockbuster new drugs. Moderna's Corona 19 mRNA vaccine, which recorded $18.4 billion in sales last year, was praised for succeeding in developing it in about a year, but the actual situation is different. Moderna's COVID-19 mRNA vaccine is the product of 30 years of RNA research, 20 years of LNP development that protects mRNA, and 10 years of Moderna's own research and development. The government recognized the biopharmaceutical industry as a 'future food in a low-growth period', a 'key field for securing jobs', and an 'essential national strategic industry for overcoming infectious diseases and other diseases and guaranteeing public health'. In order to realize this, not only R&D support measures such as active support for global clinical trials but also support measures for basic research fields such as chemistry and biotechnology from a long-term perspective must be prepared.
- Opinion
- [Reporter's view] Tagrisso's first benefit
- by Mar 27, 2023 05:56am
- AstraZeneca's lung cancer drug Tagrisso has begun receiving benefits for first-line treatment. After 5 challenges, he passed the HIRA Cancer Disease Review Board. After adding the first treatment indication in December 2018, Tagrisso actively tried to expand benefits but was rejected by the review committee every time. The reason was that looking at the data of the phase 3 sub-analysis, the effect of improving overall survival in Asians could not be confirmed. The controversy over the efficacy of Tagrisso was started by Japan and ended by Japan. In the phase 3 FLAURA clinical trial, Japan had the greatest impact in making the OS values of Asians insignificantly different from those of the control group. The medical environment where drug switching is free is a crazy aftermath. The real damage was seen by Korean patients. In Japan, the first benefit is applied regardless of the results of the sub-analysis, but in Korea, because of this data, they had to receive treatment without benefit for more than 4 years. It is also Japan that has quelled OS doubts in Asia. Last year, Japan's large-scale real-world data came out. Real-world data is not clinical in a controlled environment, so it is generally less effective than data from clinical practice. However, Tagrisso showed a longer progression-free survival period and an overall survival period of more than 3 years compared to the phase 3 trial in the Japanese real world. There is no longer any need to argue over phase 3 sub-data. Already, the first-line Tagrisso therapy has fully established itself as a global trend for EGFR-mutated non-small cell lung cancer. A German professor of hemato-oncology whom I met in an interview last year expressed some disapproval at the reporter's question, "What do you think of the sequential treatment that uses the first and second generations first and then the third generation?" This is because I had never thought about sequential therapy after Tagrisso. His answer was, "I heard that even in Germany, a small number of hospitals choose sequential treatment. However, since Tagrisso has already become the clear first-line standard treatment, to be honest, I have never thought about sequential treatment. I'm sorry I couldn't give you an answer. it was" It will take a little longer for Tagrisso to become the standard first-line therapy in Korea. Concern about cancer is just the beginning of reimbursement for anticancer drugs, and in the future, drug price negotiations with the HIRA and the NHIS, and the Ministry of Health and Welfare must all pass. Now it's a speed battle. Depending on how long it stays on the drug rating, the Tagrisso benefit expansion could be over the year or within the year. First of all, AstraZeneca has a very high will to cooperate with the government as much as possible and expedite the process. The HIRA also has many new drugs to review for reimbursement adequacy. But it's only 4 years. The fact that the first petition for Tagrisso's salary exceeded 50,000 people can be said to have reached its maximum level of desperation. I hope that their wait will not exceed 5 years.
- Opinion
- [Reporter's view]Vaccine self-sufficiency rate to 80%
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- In 2013, 10 years ago, the Ministry of Health and Welfare distributed a press release. The plan is to foster the domestic vaccine industry and raise the self-sufficiency rate of the National Immunization Vaccine to 80% by 2020. At the time, among the 28 types of National Immunization Vaccines, only 8 types of vaccines were self-sufficient, but the government's plan was to expand this to 22 types within 7 years. Only two years later, the plan to achieve 80% vaccine self-sufficiency was partially modified. The Ministry of Food and Drug Safety secretly delayed the target achievement from 2020 to 2022 at the Biopharmaceutical Global Growth Policy Forum. Four years later, the plan changed once more. The Ministry of Food and Drug Safety has delayed the goal of achieving the goal by one more year, to 2023. At the same time, the self-sufficiency rate target was lowered from 80% to 75%. Then what about the current situation? According to the KPBMA, the domestic National Immunization Vaccine self-sufficiency rate is only 50% as of 2021. This means that only 14 out of 28 types can be produced domestically. This is because many of the vaccine stocks are dependent on foreign imports. There are only six vaccines that domestic pharmaceutical companies can manufacture and supply from raw solutions to finished products, including hepatitis B, influenza, chickenpox, and tetanus/diphtheria. The self-sufficiency rate is less than 30%. Vaccine self-sufficiency is a very old issue. However, progress toward resolving the problem has been slow. The order that the vaccine self-sufficiency rate should be increased is only repeated as an empty cry every year around the state audit. Over the past three years, while the corona crisis has been prolonged, we have realized how desperate it is to secure vaccine sovereignty. As SK Bioscience succeeded in developing its own COVID-19 vaccine, it also confirmed its development capabilities. All that remains now is the motivation to drive the development and production of the National Immunization Vaccine by private companies. The solution of affordable pricing for the National Immunization Vaccine has been around for a long time. However, the slogan of securing vaccine sovereignty burns for a very short time and then goes out. While more than 10 years have passed, the plan to achieve 80% self-sufficiency in essential vaccines remains only a lofty goal. The corona crisis is turning into an endemic. In other words, great momentum is passing by to achieve the ambitious goal of securing vaccine sovereignty. We must act now. It is difficult to achieve this goal with only the pure will and efforts of private companies. It is difficult to attract participation from private companies through indirect means such as supporting vaccine R&D or improving licensing and regulation. There is a quick and sure solution called 'reasonable compensation'. Unless this solution is introduced, it is clear that the lofty goal will be revised once again before the year is out.
- Opinion
- [Reporter's view] PVA improvement plan & domestic drugs
- by Lee, Tak-Sun Mar 21, 2023 05:58am
- There is also concern about the proposal for improving PVA through research service. Last year, researchers (Bae Seung -jin, Ewha Womans University, etc.), who studied PVA's performance evaluation and improvement plan, ordered the screening management of drugs with high financial impacts. As a result, the selection criteria for the usage type 'Ka' were proposed to expand by adding 5 billion won and a 10% increase in the existing claims. Drugs with low financial impacts, such as a plan to raise the exclusion of negotiations from 2 billion won to 3 billion to 5 billion won, are required to ease management. The proposal for improvement will be discussed in May and institutionalized from January next year. In summary, the system improvement is expected to be promoted in the direction of a high -financial reduction rate, low drug reduction rate, and lowering the cut-rate. In the industry, there are many voices in favor of the system improvement direction. It is efficient to differentiate the upper limit according to the number of claims. However, there is a concern that the type of new drug will be added to the 'negotiations', and the burden will be increased to multinational pharmaceutical companies or domestic new drug development companies. In particular, domestic new drugs have been concerned about the improvement plan as the pharmaceutical industry has insisted on easing the PVA in order to ease development and encouragement. As the government uses biotechnology as a next-generation growth engine and declines domestic new drugs, it is also necessary to support the drug price. Domestic new drugs enter the low price without preferential treatment from the time of listing, and if the drug price is increased due to active sales and marketing, the new drug development company, which spends large-scale costs, ' If it was, only regret will remain. Although the government cannot discriminate against domestic and overseas new drugs, the domestic new drug preferential policy is inevitable to protect and foster our industry. Therefore, from May, we should focus on preparing more sophisticated measures in consideration of concerns about the domestic pharmaceutical industry.
- Opinion
- [Reporter’s View] ‘The smart office system’s great, but…
- by Eo, Yun-Ho Mar 15, 2023 05:56am
- The smart office system has become an industry trend. The term, which originally refers to an IT-based office near a residential area that allows employees to work remotely from satellite offices rather than commute to an office downtown, is applied a bit differently in the pharmaceutical industry. Taking into account the characteristics of the industry, as employees often have to move from office to hospital or government office, the companies created workspaces fit for such mobile environment and implemented free seating systems. Due to the telecommuting culture that naturally settled during the pandemic, the number of resident workforce had also decreased. In their place, conference rooms with various concepts and phone booths for long-term calls were added like frosting to the cake. The transition to a smart office had let companies catch two birds with one stone. The reduced number of resident workforce allowed the company to save office expenses, while more space became available for those who came to work. In fact, many multinational pharmaceutical companies that have applied the smart office system moved their offices to relatively less expensive areas. The executive-level employees gave up their space as well. To embrace the horizontal organizational culture and make space for spacious conference rooms with a view, the executives left their rooms to work next to other employees. Even the ‘bosses’ gave up their office space. “I don’t have a room either. It was awkward at first, but the change has turned out for the better. Working next to the employees, we were able to become closer and communicate better." Some companies went on to further remove the honorific expressions altogether. These companies asked employees to call their bosses ‘Mr./Ms.OO’ or by their English names. Unlike in domestic companies, many multinational company employees are known to have a more candid relationship with their bosses. However, not everyone would agree that these changes are all for the good. For example, contrasting views exist on ‘owners that dine together at employee cafeterias.’ One employee confessed “You would naturally feel nervous and uncomfortable if your boss is sitting next to you. I understand the intention and my boss is a good person, but I can’t say I am all for the situation where I have to face the highest-ranking officer of my company continuously during work.” Just as in this employee's confession, although the changes are in the right direction and follow the trend of the times, the system may need to be somewhat adjusted to suit Korea. In the cutest sense, hold a friendly ear out to the complaint and let the ‘boss’ stay in his or her room.
- Opinion
- [Reporter's view]Is the Drug Price Reduction Act Good?
- by Kim, Jin-Gu Mar 06, 2023 05:56am
- The fate of the so-called drug price reduction/refund law will be decided sooner or later. It is expected that a decision will be made within this month at the earliest, whether it will be possible to limit the tricks of avoiding drug price cuts for original drugs for several years by applying for suspension of execution. The amendment to the National Health Insurance Act, which passed the Health and Welfare Committee of the National Assembly, was initially put on hold by the Legislation and Judiciary Committee and was likely to fail. However, it was revived as the Health and Welfare Committee decided to directly refer to the plenary session centering on the opposition party. As a result, this amendment is awaiting the final decision of the plenary session of the National Assembly. The plenary session was scheduled for the 23rd and 30th of this month. In the past, there has been a fierce debate over this amendment. The Ministry of Health and Welfare and the opposition party, which favored the bill, put forward the pharmacist's trick and the leakage of health insurance finances as justification. Opposing legal circles and judiciary committees fought back with the logic that the right to request a trial, a legitimate remedy for rights guaranteed by the Constitution, was violated. In the current situation where the opposition party is the majority, the amendment bill seems to be weighted toward passage. For a resolution at the plenary session, the presence of a majority of the current members and the consent of a majority of the members present is required. In other words, the possibility of passing the plenary session, tied to other agenda items, has increased. If the amendment is finally passed, pharmaceutical companies will have to vomit the health insurance finances invested during the drug price cut suspension period if they lose the prominent lawsuit in the future. The problem is that in the process, there is a risk of shrinking the lawsuit claims of pharmaceutical companies. Of course, the abuse of the judicial system will disappear, but it is pointed out that even if the drug price cut is felt to be unfair, even the opportunity to legitimately dispute it can be limited. In terms of the judicial system, there are also criticisms that it can undermine the essence of the suspension system. The bigger problem is then. If the amendment is passed, there is a possibility that the second and third legislations that reduce the right to request a trial will follow. Legislation that limits the right to appeal for a plausible cause is only difficult for the first time and relatively easy for the second and third. The argument in favor of the amendment can be reinterpreted as not a problem if the drug companies' right to file a lawsuit is slightly reduced if it is to root out the abuse of the suspension system and thereby prevent health insurance financial leaks. No matter how repugnant a pharmaceutical company is, it cannot violate even the fundamental rights of the Constitution. It is time to think about whether the drug price reduction method is the only way to prevent pharmaceutical companies from cheating.
- Opinion
- [Reporter's view] Implications of Lucentis biosimilar
- by Lee, Tak-Sun Feb 27, 2023 05:57am
- The domestic prescription drug market is not a market where prices can operate with competitiveness. This is because paying patients do not have the option to choose a product, and doctors who have the option do not have a margin on sales of insurance drugs, so there is little incentive to prescribe low-priced products. Because of this, even generics that sell products with the same ingredients want a higher insurance limit. However, in the product market where treatment costs are high and the number of products is small, price competition sometimes takes place. A good example is Lucentis biosimilar, a treatment for macular degeneration. Only two companies, Chong Kun Dang and Samsung Bioepis, entered the market for Lucentis biosimilars in January. Both companies put pressure on the original Lucentis by setting an upper limit that was less than the calculated amount. Chong Kun Dang's generic price is 300,000 won per bottle, which is only 36.6% of the original price limit of 820,636 won. Samsung Bioepis Amelivu was listed at 463,773 won, 56% of the original 828,166 won. In the case of biosimilars, you can receive an upper limit of 80% of the original amount, but the two companies were listed at a lower price than this in consideration of price competitiveness. Samsung Bioepis Amelivu will lower the price again in March. It will be reduced by about 24.5% from the existing 463,773 won to 350,000 won. Some analyze that they were conscious of the lowest price Chong Kun Dang products. Such voluntary cut competition is very welcome from the perspective of health insurance authorities. This is because companies can see the effect of reducing insurance financial expenditures as a result of voluntary cuts. Drugs that are cheaper than the calculated amount play a role in reducing finances, but there is no great benefit either. Products with scheduled sales prices that are lower than the calculated amount may also be subject to a drug price reduction by applying PVA. If the upper limit is not lowered during the PVA monitoring period, it will be subject to the same follow-up management as other products. There are also few government incentives to enhance the market competitiveness of low-cost drugs. Although there is a policy that provides incentives to pharmacists if they substitute cheaper drugs among the same-component drugs, it is not easy for pharmacists who do not have the right to choose prescription drugs. It is difficult for patients as well as medical staff to compete for low-cost drugs in a situation where the reliability of originals is much higher than that of latecomers such as generics or biosimilars. Therefore, low-price competition is entirely the responsibility of pharmaceutical companies. Doctors who have the right to choose products should be persuaded of the justification for choosing low-cost drugs. We hope that the low-price strategy of the two pharmaceutical companies will lead to success in the Lucentis biosimilar market. It is hoped that price cuts will be activated through the appearance of low-cost drugs that are rare and competitive in the domestic market, and that this will serve as an opportunity to increase the reliability of generics. The government should also promote the positive function of generics to the market by implementing more aggressive incentive policies for pharmaceutical companies that sell low-cost drugs.
- Opinion
- [Reporter’s View] Decide whether to offer free HCV testing
- by Jung, Sae-Im Feb 24, 2023 05:53am
- Eight years have passed since discussions began on adding hepatitis C (HCV) screening as a free item in Korea’s national health examination program. Despite various supporting evidence that was produced during the period, including the feasibility study that started in 2016, and an analysis that showed that it was cost-effective to include HCV as a national health examination item, as well as the results of the pilot project, the government's intentions are still unclear. Recently, more feasibility analyses and follow-up management measures have also been released on the matter. One of the major reasons why the government was reluctant to introduce HCV screening to the national health examination was its prevalence rate. The first principle among the five conditions that must be satisfied for items to be added to the system is for the disease to be a ‘serious health condition,’ which is evaluated by whether the prevalence rate is 5% or higher. However, the prevalence rate of HCV is around 1%, therefore being unable to satisfy the condition. Its highest prevalence rate is in the 1.7% range for those aged in their 70s. Although the global prevalence rate of HCV remains below 1%, the World Health Organization has a different view on the gravity of the situation. The WHO had set the goal of eradicating HCV by 2030 and urged governments to actively implement policies on their part to achieve this goal. This goal was set as HCV can be easily cured with early diagnosis with the development of treatments, but also carries an increased risk of developing severe diseases such as liver cirrhosis or liver cancer when left untreated. The direct-acting antiviral (DAA) medications that were introduced to the field led to the era of curing HCV. Also, a retreatment option exists for the 1% of patients who fail treatment. This is why the WHO defined HCV as the next disease that can be eradicated after the smallpox virus. Even so, Korea is still stuck on the prevalence rate. An official from the Ministry of Health and Welfare who had attended the ‘32nd Conference of the Asian Pacific Association for the Study of Liver 2023 (APASL 2023),’ mentioned the prevalence rate of HCV in Korea, saying “Korea has a national health examination system in place for all citizens. Therefore, adding HCV screening as an item to the system can have a serious impact, and items should be careful and conservatively added in strict compliance with the set principles.” The remark seems to have been made to imply the authorities' stance on whether HCV screening, which has a low prevalence rate, should be included in the health examination system that is for the entire Korean population. If the prevalence rate was going to be a barrier in the first place, the government wasted more than KRW 1.3 billion in research funds on a concluded issue. No matter how cost-effective the introduction of hepatitis C screening is, all discussions become meaningless if the government raises prevalence as an absolute requirement. But diseases with a prevalence rate of less than 5% are already included for screening in the national health examination system. Therefore, the prevalence rate cannot be an absolute criterion for introducing items in the national health examination system. The government will soon be reviewing the research results that were newly presented this year. If it mentions the prevalence rate again this time, it would be safe to interpret their stance as saying, “Actually, the prevalence is just an excuse and the government has no intention of investing money in HCV." After 8 years of false hope, now is the time to draw a conclusion already.
- Opinion
- [Reporter's view] An uncomfortable gift from the gov
- by Kim, Jin-Gu Feb 17, 2023 05:50am
- The Ministry of Trade, Industry and Energy is pushing to designate key technologies used in the development of biopharmaceuticals as "national high-tech strategic technologies." If bio-core technology is designated as a state-of-the-art strategic technology, various benefits will follow. They include support for the creation of specialized complexes, training professionals through the establishment of specialized graduate schools, and tax credits. In particular, it is known that tax credits can receive up to 40% of R&D costs and up to 16% of facility investment. In November last year, the Ministry of Industry selected 15 core technologies in semiconductor, display, and secondary battery fields as state-of-the-art strategic technologies. The Ministry of Industry's plan is to provide "semiconductor-level" treatment to the pharmaceutical bio-industry by adding biotechnology. However, the pharmaceutical bio-industry is not positive about this. Some are rather opposed to the Ministry of Industry's policy. It was prepared in good faith, but the person involved did not want it. The reason why the pharmaceutical bio-industry refuses the good faith of the Ministry of Industry is because of the "regulations" accompanying support measures. The biggest concern in the industry is to require companies with related technologies to obtain approval from the Ministry of Industry when they make overseas mergers and acquisitions or establish joint ventures. The global trend of the pharmaceutical bio-industry is open innovation, which is feared to disrupt close and prompt consultations with global companies if it is approved by the Ministry of Industry every time. Furthermore, some point out whether it is appropriate for the state to intervene in transactions between companies. Some say that the pharmaceutical bio-industry and the semiconductor and display industries are physically different. In the case of the semiconductor and display industries, it is necessary to prevent the outflow of core technologies from overseas in a position where Korea leads industries around the world. On the other hand, the pharmaceutical bio-industry is still chasing the global industry. It is pointed out that it will be a burden to have to wait for the approval of the Ministry of Industry every time it is time to narrow the technology gap with global leading companies. Considering these practical benefits, the pharmaceutical bio-industry believes that losses will eventually be greater than profits. Currently, the Ministry of Trade, Industry, and Energy is collecting industry opinions to designate the nation's state-of-the-art strategic technology for core biotechnologies. In this regard, related organizations such as the Korea Pharmaceutical Bio Association are reportedly planning to convey the opposite position. It is hard to say that the Ministry of Industry's intention to provide semiconductor-level treatment to the pharmaceutical bio-industry itself was bad. But there is no guarantee that a good start will necessarily produce good results. The starting point for fostering and supporting the pharmaceutical bio-industry may be to look at the industry from the perspective of the pharmaceutical bio industry.
